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临床试验/NCT06806319
NCT06806319已完成2 期

Soft Tissue Crown Lengthening and Attached Gingiva Remodeling: Assessment of Growth Factors Levels Associated with Wound Healing

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年10月3日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
80
试验地点
1
主要终点
Epithelization rate

研究概览

简要总结

Clinicians often encounter the need for crown lengthening in the practice of dentistry and have to make treatment decisions taking into consideration how to best address the biological, functional, and esthetic requirements of each particular case. The concept of crown lengthening was first introduced by D.W. Cohen (1962) and is presently a procedure that often employs some combination of tissue reduction or removal , osseous surgery , and/or orthodontics for tooth exposure and increasing the extent of supra gingival tooth structure for restoration of aesthetic purposes . Gingivectomy and gingivoplasty considered kind of crown lengthening procedure. Gingivectomy is defined as the excision of the soft tissue wall of a pocket. The procedure is usually combined with the recontouring of hyperplastic tissue by gingivectoplasty to restore physiological gingival form . Gingivoplasty is a reshaping of the gingiva to create physiologic gingival contours, with the sole purpose of recontouring the gingiva in the absence of pockets. In doing so, the complete anatomical crown becomes exposed and pseudo pockets are eliminated creating a better environment for periodontal health. Treatment options for crown lengthening procedures include: Surgical, Electrocautery or by Laser. The aim of the present study was to compare the practical effectiveness and postoperative parameters of using diode laser and electrocautery for crown lengthening procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Men and women aged ≥ 18 years.
  • •Patients with short clinical crowns to enhance esthetic, exposure of subgingival caries for prosthetic replacement, exposure of a fracture or combination.
  • •All patients were free from any systemic diseases according to the criteria of Modified Cornell Medical Index.
  • •All patients need soft tissue removal and don't need osseous resection.
  • •Full-Mouth Plaque Score (FMPS) ≤ 20% at baseline.
  • •Full-Mouth Bleeding Score (FMBS) ≤ 20% at baseline.

排除标准

  • •Light smokers i.e. smoking > 10 cigarettes/day.
  • •Patients with medical conditions contraindicating surgical interventions.
  • •Pregnancy or lactation.
  • •Patients with active periodontal disease (PD ≥ 6 mm)
  • •Clinical and/or radiographic signs of periapical pathology.
  • •Patients with pacemakers.

研究组 & 干预措施

Laser crown lengthening technique

Active Comparator

1-The patients were anesthetized using infiltration technique and/ or nerve block. 2-Specific protective glasses were used for patient, dentist, and assistant. Highly reflective instruments or instruments with mirrored surface were voided as there could be reflection of the laser beam. 3- The pocket depths in the surgical site were measured. Dots made in the gingiva by using Krane Kaplen tweezer, then area to be cut outlined by connection of dots (fig.6(D)) using Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μm (fig.8). 4-Continue to split the dots halfway until there was a continuing line of dots by using the diode laser, 5-During the entire procedure, the tip was constantly checked for any debris of the ablated tissues and was cleaned with sterile moist gauze.6-Physiological gingival contour was achieved by changing the angulation of the tip as required during the procedure. 7-After the surgery, the end of the fiber (2-3mm)

干预措施: single intervention by Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μm (Device)

Electrocautery crown lengthening

Active Comparator

1-Patients were anesthetized by infiltration technique and/ or nerve block 2-The pocket depths in the surgical site were measured using crane Kaplan tweezer. 3-Patient asked to hold the reusable silicone patient plate. 4-The output power of electrosurgical unit (fig.6) was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%. 5-Continue to split the dots halfway until there was a continuing line of dots. 6-Avoid the operation of equipment in a room with flammable or explosive materials. 7-Rapid, well-planned movements without pressure and it should be like brushing strokes keep electrode moving all the time, use high enough current. 8-A cooling period of 8 seconds should be allowed between successive incisions with the electrode. 9-Continuous saline irrigation was given while using the electrocautery. 10-The excised tissues are removed with Orban knife.

干预措施: single intervention by electrosurgical unit which was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%. (Device)

结局指标

主要结局

Epithelization rate

时间窗: From enrollment to the end of treatment at 3 weeks

After gingivectomy operation, the surgical site was evaluated with hydrogen peroxide to detect the presence of epithelization. The mesio-distal width of the maxillary right central tooth was recorded for each patient, and photographs were calibrated via the reference values. all photographs were examined with the assistance of Image processing and analysis in Java, Image J software. In the areas subjected to hydrogen peroxide application and experiencing tissue reaction, there was a lack of an epithelial layer in the wound area.

Transforming Growth Factor-β1 (TGF-β1) levels assessment

时间窗: From enrollment to the end of treatment at 8 weeks

The levels of TGF-β1 in the GCF samples were determined using commercially available ELISA Kits

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asem Mohammed Kamel Ali

Director

Al-Azhar University

研究点 (1)

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